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JP6416774B2 - Injection device with needle protection system - Google Patents

Injection device with needle protection system Download PDF

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Publication number
JP6416774B2
JP6416774B2 JP2015547119A JP2015547119A JP6416774B2 JP 6416774 B2 JP6416774 B2 JP 6416774B2 JP 2015547119 A JP2015547119 A JP 2015547119A JP 2015547119 A JP2015547119 A JP 2015547119A JP 6416774 B2 JP6416774 B2 JP 6416774B2
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Prior art keywords
needle protection
needle
injection device
radial
protection member
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JP2016503672A (en
Inventor
アルノー フルニエ
アルノー フルニエ
ジスラン フルニエ
ジスラン フルニエ
ミカエル スワル
ミカエル スワル
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Aptar Stelmi SAS
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Aptar Stelmi SAS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A61M5/3204—Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3107—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle for needles
    • A61M2005/3109—Caps sealing the needle bore by use of, e.g. air-hardening adhesive, elastomer or epoxy resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Environmental & Geological Engineering (AREA)

Description

本発明は、針保護システムを有する注射装置に関する。   The present invention relates to an injection device having a needle protection system.

注射装置は、よく知られており、一般に、送出されるべき流体を収容するシリンジを有する本体部を備える。この本体部は、シリンジのピストンを移動させるために適応される送り出し手段が組み込まれており、これによって注射が実行される。
よく知られている注射装置の一つのタイプとして、自己注射器がある。自己注射器においては、ひとつもしくはそれ以上のバネによって、注射が自動的に行われる。 Injection devices are well known and generally comprise a body having a syringe that contains the fluid to be delivered. This body portion incorporates delivery means adapted to move the piston of the syringe, whereby injection is performed.
One type of injection device that is well known is a self-injector. In self-injectors, injection is automatically performed by one or more springs.

そのようなタイプの注射装置においては、注射する前に、シリンジの針が保護されている必要があり、特に、殺菌された状態に保たれている必要がある。
この目的のため、例えば、特許文献１および特許文献２に記載されているような取り外し可能な針保護部材の使用が知られている。
そのようなタイプの針保護部材は、一般的に柔軟な材料からなる隔離部を含み、その中に、吐出口を含む針の先端部を、保護位置あるいは非吐出位置において、突き刺すようになっている。 In such type of injection device, the needle of the syringe needs to be protected and, in particular, needs to be kept sterilized before injection.
For this purpose, it is known to use a removable needle protection member as described, for example, in US Pat.
Such a type of needle protection member generally includes an isolating portion made of a flexible material, and pierces the tip of the needle including the discharge port in a protected position or a non-discharge position. Yes.

ユーザーが注射装置を使用したいときは、針保護部材を手で除去し、針を開放し、それから流体を注射できるようにする。
このタイプの注射装置にあっては、注射装置を操作する人の安全性に関して問題が生じる。特に、針保護部材を除去した後、もしくは除去している最中に、針に刺されるおそれがある。 When the user wants to use the injection device, the needle protection member is removed by hand, the needle is opened, and then fluid can be injected.
With this type of injection device, problems arise with regard to the safety of the person operating the injection device. In particular, the needle may be stabbed after the needle protection member is removed or during the removal.

その上、特に、自己注射器の場合には、針保護部材をその保護位置もしくは非吐出位置から除去する動作も、信頼性があり、できるだけ簡単でなければならない。   In addition, particularly in the case of a self-injector, the operation of removing the needle protection member from its protected or non-ejection position must be reliable and as simple as possible.

フランス特許公開公報第２７７７７８７号French Patent Publication No. 2777787 フランス特許公開公報第２８１６８４８号French Patent Publication No. 2816848 国際公開公報２００９／０８１１０３International Publication No. 2009/081103 国際公開公報２０１２／１６４３９７International Publication No. 2012/164397 欧州特許公開公報０５１８４１６号European Patent Publication 0518416 国際公開公報００／０９１８６International Publication No. 00/09186 アメリカ特許公開公報４９８６８１８号US Patent Publication No. 4986818 国際公開公報２００４／１１０５３５号International Publication No. 2004/110535 国際公開公報２００９／８７３５５号International Publication No. 2009/87355 ドイツ特許公開公報１０２００８００３１８５号German Patent Publication No. 102008003185

本発明の目的は、上述のような欠点を有さない針保護システムを含む注射装置を提供することである。
特に、本発明の目的は、製造・組立が簡易かつ安価で、しかも、使用における信頼性が高い針保護システムを提供することである。 The object of the present invention is to provide an injection device comprising a needle protection system which does not have the disadvantages mentioned above.
In particular, an object of the present invention is to provide a needle protection system that is simple and inexpensive to manufacture and assemble, and that is highly reliable in use.

そのため、本発明は、針保護システムを含む注射装置であって、吐出口を有する吐出針を含み、前記針保護システムが、非吐出位置において吐出針の吐出口を保護し隔離するために、吐出針の周囲に配される移動可能な針保護部材を備え、前記針保護部材は中空の側面体部と隔離部とを含み、少なくとも隔離部は、柔軟な材料で形成され、非吐出位置において、吐出針の吐出口が、前記隔離部に突き刺されるようになっており、前記針保護部材が少なくとも一つの径方向外側へ突出する径方向突出部を備え、前記保護システムは、さらに、グリップ手段が設けられた外側キャップ部材を備え、このグリップ手段は、前記針保護部材の少なくとも一つの径方向突出部と協働し、外側キャップ部材を吐出針の長手方向の吐出口から離れる方向に移動させることにより、非吐出位置から針保護部材を除去し、前記少なくとも一つの径方向突出部は、針保護部材の軸方向末端部に配され、かつ、前記少なくとも一つの径方向突出部は、針保護部材の堅い外側構造物に形成されることを特徴とする。   Therefore, the present invention is an injection device including a needle protection system, which includes a discharge needle having a discharge port, and the needle protection system discharges in order to protect and isolate the discharge port of the discharge needle in a non-discharge position. A movable needle protection member disposed around the needle, the needle protection member including a hollow side body part and an isolation part, at least the isolation part being formed of a flexible material, The discharge port of the discharge needle is pierced by the isolation part, the needle protection member includes at least one radial protrusion protruding outward in the radial direction, and the protection system further includes grip means. Provided with an outer cap member, which grip means cooperates with at least one radial protrusion of the needle protection member to move the outer cap member away from the longitudinal outlet of the discharge needle. By removing the needle protection member from the non-ejection position, the at least one radial protrusion is disposed at an axial end of the needle protection member, and the at least one radial protrusion is a needle The protective member is formed in a rigid outer structure.

前記少なくとも一つの径方向突出部は、周辺へ向かって径方向に突出する突出部を形作る円盤によって形成されていることが望ましい。
前記グリップ手段は、前記外側キャップ部材の内側に向けて径方向に伸び、特にスナップ留めによって、前記針保護部材の少なくとも一つの径方向突出部と協働する、少なくとも一つの径方向肩部を備えることが望ましい。 The at least one radial protrusion is preferably formed by a disk that forms a protrusion protruding radially toward the periphery.
The grip means comprises at least one radial shoulder that extends radially inward of the outer cap member and cooperates with at least one radial protrusion of the needle protection member, in particular by snapping. It is desirable.

前記少なくとも一つの径方向肩部は、径方向全周フランジ、または、周方向に分散した複数の径方向フランジ部分からなることが望ましい。
前記少なくとも一つの肩部は、変形可能なタブによって形成されていることが望ましい。
前記グリップ手段は、前記少なくとも一つの径方向突出部の径方向外側エッジと、押し嵌りまたは摩擦により協働する、円錐状の内面を有することが望ましい。 Preferably, the at least one radial shoulder portion is composed of a radial all-around flange or a plurality of radial flange portions dispersed in the circumferential direction.
The at least one shoulder is preferably formed by a deformable tab.
The grip means preferably has a conical inner surface that cooperates with a radially outer edge of the at least one radial protrusion and with a press fit or friction.

前記グリップ手段は、前記外側キャップ部材と一体的に形成されていることが望ましい。
前記グリップ手段は、前記外側キャップ部材に対して移動可能な内部部品に形成されているとしてもよい。
外側キャップ部材を針保護部材の周囲に装着する際に、非吐出位置にある針保護部材と機械的に当接して協働するリングを備えることが望ましい。 The grip means is preferably formed integrally with the outer cap member.
The grip means may be formed in an internal part movable with respect to the outer cap member.
When the outer cap member is mounted around the needle protection member, it is desirable to provide a ring that mechanically contacts and cooperates with the needle protection member in the non-ejection position.

前記注射装置は、自己注射器であることとしてもよい。
本発明における、特徴と有用性およびその他の事項は、以下の図面を参照して、非限定的な実施の形態に基づき、より明らかになる。 The injection device may be a self-injector.
Features and usefulness and other matters in the present invention will become more apparent based on non-limiting embodiments with reference to the following drawings.

本発明の第１の実施の形態における、針保護システムを含む注射装置の一部切り欠き斜視図である。It is a partially cutaway perspective view of an injection device including a needle protection system in the first embodiment of the present invention. 図１の注射装置の一部分の断面図である。2 is a cross-sectional view of a portion of the injection device of FIG. 本発明の第２の実施の形態における、図１と同様な斜視図である。It is a perspective view similar to FIG. 1 in the 2nd Embodiment of this invention. 本発明の異なる実施の形態における、組立前の注射装置の一部切り欠き斜視図である。It is a partially cutaway perspective view of an injection device before assembly in different embodiments of the present invention. 本発明の上記異なる実施の形態における、組立後の注射装置の一部切り欠き斜視図である。It is a partially cutaway perspective view of the injection device after assembly in the different embodiment of the present invention. 本発明の別の実施の形態における、図４と同様な組立前の斜視図である。FIG. 5 is a perspective view before assembly, similar to FIG. 4, in another embodiment of the present invention. 本発明の上記別の実施の形態における、図５と同様な組立後の斜視図である。FIG. 6 is a perspective view after assembly similar to that of FIG. 5 according to another embodiment of the present invention. 本発明のさらに別の実施の形態における、図４と同様な組立前の斜視図である。FIG. 5 is a perspective view before assembly, similar to FIG. 4, in yet another embodiment of the present invention. 本発明の上記さらに別の実施の形態における、図５と同様な組立後の斜視図である。FIG. 6 is a perspective view after assembling similar to FIG. 5 in the still another embodiment of the present invention. 本発明のさらに別の実施の形態における、図４と同様な組立前の斜視図である。FIG. 5 is a perspective view before assembly, similar to FIG. 4, in yet another embodiment of the present invention. 本発明の上記さらに別の実施の形態における、図５と同様な組立後の斜視図である。FIG. 6 is a perspective view after assembling similar to FIG. 5 in the still another embodiment of the present invention. 本発明のさらに別の実施の形態を示す図である。It is a figure which shows another embodiment of this invention. 図１２の次の工程を示す図である。FIG. 13 is a diagram showing a step subsequent to FIG. 12. 図１３の状態における一部切り欠き図である。It is a partially cutaway view in the state of FIG. 本発明のさらに別の実施の形態を示す図である。It is a figure which shows another embodiment of this invention. 図１５の実施の形態における組立後の様子を示す図である。It is a figure which shows the mode after the assembly in embodiment of FIG. 本発明でカバーされていない他の実施の形態を示す断面図であって、非吐出位置での状態を示す図である。It is sectional drawing which shows other embodiment which is not covered by this invention, Comprising: It is a figure which shows the state in a non-ejection position. 図１７に示す実施の形態と同様の図を別の方向から見たときの図である。It is a figure when the same figure as embodiment shown in FIG. 17 is seen from another direction.

図１と図２は、本発明の第１の実施の形態を示す。
第１の実施の形態として、例えば自己注射器のような注射装置を図面に示す。
自己注射器は、注射されるべき流体を収納する容器となるシリンジ２を内包する外側本体１を含む。
上記シリンジ２は、針１０を備える先端部３を有する。当該針１０は、その軸上の末端部、すなわち、容器から最も離れた軸上の端部に、吐出口１１を有する。 1 and 2 show a first embodiment of the present invention.
As a first embodiment, an injection device such as a self-injector is shown in the drawings.
The self-injector includes an outer body 1 that contains a syringe 2 that serves as a container for containing a fluid to be injected.
The syringe 2 has a distal end portion 3 provided with a needle 10. The needle 10 has a discharge port 11 at the end on its axis, that is, the end on the axis farthest from the container.

図２に示すように、非吐出位置にある針１０をカバーするため、移動可能な針保護部材２０が設けられている。
知られているように、針保護部材２０は、柔軟な材料で形成され、針１０の吐出口１１が、突き刺される隔離部２１を含む。これにより、針を隔離し、シリンジ２の内容物を無菌状態に維持するようになっている。 As shown in FIG. 2, a movable needle protection member 20 is provided to cover the needle 10 in the non-ejection position.
As is known, the needle protection member 20 is formed of a flexible material and includes an isolation part 21 into which the discharge port 11 of the needle 10 is pierced. Thereby, the needle is isolated and the contents of the syringe 2 are maintained in a sterile state.

知られているように、針保護部材２０は、基部に近い方に、シリンジ２の先端部３に嵌合するための開口を有し、柔軟な材料からなる隔離部２１によって末端側の他の端部において閉塞された、中空の側面体部２７を含む。
オプションとして、図１、２の実施の形態に示されるように、側面体部２７も、柔軟な材料で形成されてもよい。 As is known, the needle protection member 20 has an opening for fitting to the distal end portion 3 of the syringe 2 on the side closer to the base portion, and is separated from the other end side by an isolation portion 21 made of a flexible material. It includes a hollow side body portion 27 closed at the end.
Optionally, as shown in the embodiment of FIGS. 1 and 2, the side body 27 may also be formed of a flexible material.

針保護部材２０よりも堅い材料で形成された外側構造物２８が、特に針保護部材２０を強化するために、側面体部２７の周りに設けられる。
このような２種類の材料からなる針保護部材２０は、良く知られており、とりわけ上述の公報にも記載されている。
たとえば、針保護部材２０の柔軟な部分は、ゴム材料もしくは熱可塑性のエラストマーで形成されてよい。 An outer structure 28 formed of a material stiffer than the needle protection member 20 is provided around the side body portion 27 in order to strengthen the needle protection member 20 in particular.
The needle protection member 20 made of such two kinds of materials is well known, and is described in the above-mentioned publication.
For example, the flexible portion of the needle protection member 20 may be formed of a rubber material or a thermoplastic elastomer.

堅い部分は、ポリプロピレン（ＰＰ）などの適当な樹脂材料から形成されてよい。
変形例として、堅い部分は、部分的もしくは全体を鉄などの金属で形成することもできるだろう。
本発明では、針保護部材２０は少なくとも１個の、径方向外側に向けて伸びる径方向突出部２５を含む。特に、径方向突出部２５は、円盤状に形成されてもよい。 The stiff portion may be formed from a suitable resin material such as polypropylene (PP).
As a variant, the rigid part could be partly or wholly formed of a metal such as iron.
In the present invention, the needle protection member 20 includes at least one radial protrusion 25 extending radially outward. In particular, the radial protrusion 25 may be formed in a disk shape.

図１、２に示すように、径方向突出部２５は、針保護部材２０の軸方向末端部に固定されるか、形成される。
変形例として、針保護部材２０の軸方向末端部の周囲に複数の突出体が配置されてもよい。
本発明では、図１〜１６に示されているように、径方向突出部２５は、堅い外側構造物２８に形成されている。 As shown in FIGS. 1 and 2, the radial protrusion 25 is fixed to or formed at the axial end of the needle protection member 20.
As a modification, a plurality of protrusions may be disposed around the axial end portion of the needle protection member 20.
In the present invention, the radial protrusion 25 is formed in a rigid outer structure 28 as shown in FIGS.

望ましくは、堅い外側構造物２８は、１以上の側面部スロット（溝穴）２６を含む。オプションとして、堅い外側構造物２８と径方向突出部２５との間には半径方向に後退する凹部２２を形成してもよい。
図１７、１８に示す、本発明でカバーされない変形例では、径方向突出部２５は、針保護部材２０の側面体部２７に直接形成されている。 Desirably, the rigid outer structure 28 includes one or more side slots (slots) 26. Optionally, a recess 22 may be formed between the rigid outer structure 28 and the radial protrusion 25 that recedes in the radial direction.
In the modification example shown in FIGS. 17 and 18 and not covered by the present invention, the radial protrusion 25 is formed directly on the side body 27 of the needle protection member 20.

この構成では、柔軟な材料から作り出すため、径方向突出部２５を含む針保護部材２０が複雑になるという欠点を呈する。
加えて、径方向の肩部も柔軟な材料で形成されるので、変形して、その作用の妨げとなる。
図１７、１８からも分かるように、この変形例においては、径方向突出部２５の外形が側面体部２７の外形よりも大きいことが望ましい。 In this structure, since it produces from a flexible material, the needle protection member 20 containing the radial direction protrusion part 25 exhibits the fault that it becomes complicated.
In addition, since the shoulder portion in the radial direction is also made of a flexible material, it deforms and hinders its action.
As can be seen from FIGS. 17 and 18, in this modification, it is desirable that the outer shape of the radially projecting portion 25 is larger than the outer shape of the side body portion 27.

なお、図１７、１８の実施の形態では、針保護部材２０に堅い外側構造物を加えれば、本発明でカバーされるであろう。
本発明の針保護システムにおいては、針保護部材２０の周囲に係合すると共に、針保護部材２０の少なくとも一つの径方向突出部２５と協働するグリップ手段（grip means）を含む外側キャップ部材３０を含む。 In the embodiment of FIGS. 17 and 18, if a stiff outer structure is added to the needle protection member 20, it will be covered by the present invention.
In the needle protection system of the present invention, the outer cap member 30 includes a grip means that engages around the needle protection member 20 and cooperates with at least one radial protrusion 25 of the needle protection member 20. including.

望ましくは、グリップ手段は、外側キャップ部材３０の内側の表面から径方向内側に伸びる少なくとも一つの径方向肩部を含むのが望ましい。
図１と図２を参照して分かるように、径方向肩部は外側キャップ部材３０の内側表面から径方向内側に向けてその内周に連続して突出するフランジ３５によって形成され、針保護部材２０の径方向突出部２５の下方にスナップ留めされる。 Desirably, the gripping means includes at least one radial shoulder extending radially inward from the inner surface of the outer cap member 30.
As can be seen with reference to FIGS. 1 and 2, the radial shoulder is formed by a flange 35 continuously projecting from the inner surface of the outer cap member 30 toward the inner side in the radial direction, and the needle protection member. Snaps under 20 radial protrusions 25.

ユーザーが、外側キャップ部材３０を、針１０の長手方向において軸に沿って移動させて、吐出口１１から除去すると、針保護部材２０は、その保護位置あるいは非吐出位置から移動され、それによって図１に示されるように針１０が解放される。
図４から図９に、外側キャップ部材３０の少なくとも一つの径方向肩部の様々な変形例を示す。 When the user moves the outer cap member 30 along the axis in the longitudinal direction of the needle 10 and removes it from the discharge port 11, the needle protection member 20 is moved from its protected position or non-discharge position. The needle 10 is released as indicated at 1.
4 to 9 show various modifications of at least one radial shoulder of the outer cap member 30. FIG.

図２では、径方向肩部は、外側キャップ部材３０内側の内周に沿った一つのフランジ３５によって形成されていたが、図８に示すように複数に分割された径方向フランジ状の突出部３５’が設けられていてももちろん構わない。
さらに変形例として、図４、５に示すように、径方向突出部２５方向に軸に沿って向かう、変形可能な複数のタブ３６であってもよいし、図６、７に示すように、反対方向に向かうスナップ留め用タブ３６であってもよい。 In FIG. 2, the radial shoulder portion is formed by one flange 35 along the inner periphery of the outer cap member 30. However, as shown in FIG. 8, the radial flange-shaped protrusion is divided into a plurality of portions. Of course, it does not matter if 35 'is provided.
Further, as a modification, as shown in FIGS. 4 and 5, there may be a plurality of deformable tabs 36 along the axis in the radial projecting portion 25 direction, or as shown in FIGS. It may be a snap tab 36 that faces in the opposite direction.

当然、どんなタイプの突出部に協働するどんなタイプの肩部であっても、外側キャップ部材３０を針保護部材２０に協働させるため、本発明の趣旨に沿うものであればよい。
図１０、１１では、外側キャップ部材３０は、内部の径方向肩部を含んでいないが、末端の径方向突出部２５の径方向外側のエッジと、押し嵌り（jam)もしくは摩擦により協働するように円錐状の内面を有する。 Of course, any type of shoulder that cooperates with any type of protrusion may be in accordance with the spirit of the present invention in order for the outer cap member 30 to cooperate with the needle protection member 20.
In FIGS. 10 and 11, the outer cap member 30 does not include an inner radial shoulder, but cooperates with the radially outer edge of the distal radial protrusion 25 by a jam or friction. So as to have a conical inner surface.

図１２から図１４は、さらに別の変形例を示すものであって、外部グリップ部材３００が、外側キャップ部材３０と針保護部材２０における少なくとも一つの径方向突出部２５と協働するものである。
望ましくは、外部グリップ部材３００は、Ｕ字形状のクリップまたはピンであり、外側キャップ部材３０を針保護部材２０に被せた後、外側キャップ部材３０の開口部３０１に挿通されて、図１４に示すように径方向突出部２５の下方に位置するようになっている。 12 to 14 show still another modified example in which the external grip member 300 cooperates with at least one radial protrusion 25 in the outer cap member 30 and the needle protection member 20. .
Desirably, the external grip member 300 is a U-shaped clip or pin, and after the outer cap member 30 is put on the needle protection member 20, the outer grip member 300 is inserted into the opening 301 of the outer cap member 30 and shown in FIG. 14. Thus, it is located below the radial protrusion 25.

この例では、追加部品が必要だが、外側キャップ部材３０の複雑さは低減する。
針保護部材２０の外側端部に形成され、外側キャップ部材３０のグリップ手段と協働する径方向突出部２５の使用により、とりわけ製造と組立が簡単になり、使用における信頼性が得られる。
図１５、１６は、シリンジ２の周りであって、シリンジ２の先端部３に近い位置に、リング２００が追加された変形例を示すものである。リング２００の目的は、針保護部材２０の外側構造物２８の軸方向後端側のエッジと協働することである。 In this example, additional parts are required, but the complexity of the outer cap member 30 is reduced.
The use of radial projections 25 formed at the outer end of the needle protection member 20 and cooperating with the grip means of the outer cap member 30 makes it easier to manufacture and assemble, especially for reliability in use.
FIGS. 15 and 16 show a modification in which a ring 200 is added around the syringe 2 at a position close to the distal end portion 3 of the syringe 2. The purpose of the ring 200 is to cooperate with the edge on the axially rear end side of the outer structure 28 of the needle protection member 20.

リング２００は、注射装置の構成要素としてもよい。リング２００は、針保護部材２０と協働する軸方向前側エッジ２０８を有する指状部材２０１を含む。
外側キャップ部材３０を針保護部材２０に押し込んで装着する際、指状部材２０１が機械的に当接して、針保護部材２０が並進移動するのを阻止することができる。
そして、外側キャップ部材３０を装着する際に生じる力は、針保護部材２０の外側構造物２８とリング２００の指状部材２０１間の接触を介して、直接伝達される。 The ring 200 may be a component of the injection device. The ring 200 includes a finger 201 having an axial front edge 208 that cooperates with the needle protection member 20.
When the outer cap member 30 is pushed into the needle protection member 20 and attached, the finger-like member 201 can be mechanically contacted to prevent the needle protection member 20 from being translated.
The force generated when the outer cap member 30 is attached is directly transmitted through the contact between the outer structure 28 of the needle protection member 20 and the finger member 201 of the ring 200.

このようにして、針保護部材２０は、外側キャップ部材３０が装着されている間、移動しない、これによって、装置の組立性を維持しつつ、針へのダメージを避けることができる。
図３は、図１、２の注射装置の変形実施例であって、外側キャップ部材３０の径方向肩部３５は、図１、２の実施例のように外側キャップ部材３０と一体的に形成されておらず、外側キャップ部材３０内を移動可能な可動部材３９に形成されている。 In this way, the needle protection member 20 does not move while the outer cap member 30 is attached, thereby avoiding damage to the needle while maintaining assembly of the device.
FIG. 3 shows a modified embodiment of the injection device of FIGS. 1 and 2, and the radial shoulder 35 of the outer cap member 30 is formed integrally with the outer cap member 30 as in the embodiment of FIGS. The movable member 39 that is movable in the outer cap member 30 is not formed.

図１７、１８は、本発明によってカバーされない別の実施例である。なぜなら、針保護部材２０が外側構造物２８を具備していないからである。
この変形実施例では、外側キャップ部材３０は、より複雑な形状となっている。
図１７、１８における外側キャップ部材３０が、径方向突出部２５を保持する外側構造物２８を有する針保護部材２０に適用される場合には、本発明によってカバーされることになる。 17 and 18 are alternative embodiments not covered by the present invention. This is because the needle protection member 20 does not include the outer structure 28.
In this modified embodiment, the outer cap member 30 has a more complicated shape.
When the outer cap member 30 in FIGS. 17 and 18 is applied to the needle protection member 20 having the outer structure 28 that holds the radial protrusion 25, it is covered by the present invention.

この変形実施例では、外側キャップ部材３０は、内側スリーブ３３と外側スリーブ３４とを備える。
外側スリーブ３４は、外側キャップ部材３０の外側の部分を形作り、一方、内側スリーブ３３は、針保護部材２０、特に径方向突出部２５と協働する。
外側キャップ部材３０の内側スリーブ３３は、図１８に示すように、内方に突出し、内側スリーブ３３の周方向に配置された複数の変形可能タブ３６を伴って作られもよい。 In this modified embodiment, the outer cap member 30 includes an inner sleeve 33 and an outer sleeve 34.
The outer sleeve 34 forms the outer part of the outer cap member 30, while the inner sleeve 33 cooperates with the needle protection member 20, in particular the radial protrusion 25.
The inner sleeve 33 of the outer cap member 30 may be made with a plurality of deformable tabs 36 that project inward and are disposed in the circumferential direction of the inner sleeve 33, as shown in FIG.

特に、変形可能タブ３６は、内側スリーブ３３の長手方向または軸方向の開口部に形成される。
図１７に示すように、自己注射器に対して外側キャップ部材３０を安定化するための安定化タブ３７が、外側スリーブ３４と内側スリーブ３３の間に設けられてもよい。
特許請求の範囲によって定義される本発明の範囲を超えない範囲で他の変形例が考えられる。 In particular, the deformable tab 36 is formed in the longitudinal or axial opening of the inner sleeve 33.
As shown in FIG. 17, a stabilization tab 37 may be provided between the outer sleeve 34 and the inner sleeve 33 for stabilizing the outer cap member 30 with respect to the self-injector.
Other variations are possible without departing from the scope of the invention as defined by the claims.

Claims (8)

外側本体（１）と、前記外側本体（１）内に収容されるシリンジ（２）と、前記シリンジの吐出針（１０）を保護する針保護システムとを含む注射装置であって、
前記針保護システムが、
非吐出位置において前記吐出針（１０）の吐出口（１１）を保護し隔離するために、前記吐出針（１０）の周囲に配される移動可能な針保護部材（２０）を備え、
前記針保護部材（２０）は、内部本体と外側構造物（２８）とからなり、
前記内部本体は、中空の側面体部（２７）と隔離部（２１）とを含み、少なくとも隔離部（２１）は、柔軟な材料で形成され、非吐出位置において、前記吐出針（１０）の吐出口（１１）が、前記隔離部（２１）に突き刺されるようになっており、
前記外側構造物（２８）は、前記内部本体よりも硬い材料で形成され、前記内部本体の外周を覆うように配されて前記内部本体を補強し、
前記針保護部材（２０）の外側構造物（２８）の、前記シリンジ（２）から遠位側にある軸方向末端部に、少なくとも一つの径方向外側へ突出する径方向突出部（２５）が設けられ、
前記針保護システムは、さらに、グリップ手段（３５、３５’、３６；３８；３００）が設けられた外側キャップ部材（３０）を備え、このグリップ手段は、前記針保護部材（２０）の少なくとも一つの径方向突出部（２５）と協働し、外側キャップ部材（３０）を吐出針（１０）の長手方向の吐出口（１１）から離れる方向に移動させることにより、非吐出位置から針保護部材（２０）を除去するようになっており、
前記グリップ手段（３５、３５’、３６）は、前記外側キャップ部材（３０）に対して移動可能な内部部品（３９）に形成されている
ことを特徴とする注射装置。 An injection device comprising an outer body (1), a syringe (2) accommodated in the outer body (1), and a needle protection system for protecting the discharge needle (10) of the syringe,
The needle protection system is
In order to protect and isolate the discharge port (11) of the discharge needle (10) in the non-discharge position, a movable needle protection member (20) disposed around the discharge needle (10) is provided.
The needle protection member (20) comprises an inner body and an outer structure (28),
The inner body includes a hollow side body part (27) and an isolation part (21), and at least the isolation part (21) is formed of a flexible material, and in the non-ejection position, the ejection needle (10) The discharge port (11) is pierced by the isolation part (21),
The outer structure (28) is formed of a material harder than the inner body, and is arranged so as to cover an outer periphery of the inner body to reinforce the inner body.
At least one radial protrusion (25) protruding outward in the radial direction is provided at an axial end of the outer structure (28) of the needle protection member (20) on the distal side from the syringe (2). Provided,
The needle protection system further comprises an outer cap member (30) provided with grip means (35, 35 ', 36; 38; 300), which grip means is at least one of the needle protection members (20). In cooperation with the two radial protrusions (25), the outer cap member (30) is moved away from the discharge port (11) in the longitudinal direction of the discharge needle (10) to move the needle protection member from the non-discharge position. (20) is to be removed ,
The injection device characterized in that the grip means (35, 35 ', 36) are formed in an internal part (39) movable relative to the outer cap member (30) . 前記少なくとも一つの径方向突出部（２５）は、周辺へ向かって径方向に突出する突出部を形作る円盤によって形成されている
ことを特徴とする請求項１に記載の注射装置。 The injection device according to claim 1, wherein the at least one radial protrusion (25) is formed by a disk that forms a protrusion protruding radially toward the periphery. 前記グリップ手段は、前記外側キャップ部材（３０）の内側に向けて径方向に伸び、特にスナップ留めによって、前記針保護部材（２０）の少なくとも一つの径方向突出部（２５）と協働する、少なくとも一つの径方向肩部（３５、３５’、３６）を備える
ことを特徴とする請求項１または２に記載の注射装置。 The grip means extends radially inwardly of the outer cap member (30) and cooperates with at least one radial protrusion (25) of the needle protection member (20), in particular by snapping. 3. Injection device according to claim 1 or 2, characterized in that it comprises at least one radial shoulder (35, 35 ', 36). 前記少なくとも一つの径方向肩部は、径方向全周フランジ（３５）、または、周方向に分散した複数の径方向フランジ部分（３５’）からなる
ことを特徴とする請求項３に記載の注射装置。 The injection according to claim 3, wherein the at least one radial shoulder comprises a radial circumferential flange (35) or a plurality of radial flange portions (35 ') distributed in the circumferential direction. apparatus. 前記少なくとも一つの径方向肩部は、変形可能なタブ（３６）によって形成されている
ことを特徴とする請求項３に記載の注射装置。 4. The injection device according to claim 3, wherein the at least one radial shoulder is formed by a deformable tab (36). 前記グリップ手段は、前記少なくとも一つの径方向突出部（２５）の径方向外側エッジと、押し嵌りまたは摩擦により協働する、円錐状の内面（３８）を有する
ことを特徴とする請求項１から５までのいずれかに記載の注射装置。 The gripping means has a conical inner surface (38) cooperating with the radially outer edge of the at least one radial protrusion (25) by press fit or friction. The injection device according to any one of 5 to 5. 外側キャップ部材（３０）を針保護部材（２０）の周囲に装着する際に、非吐出位置にある針保護部材（２０）と機械的に当接して協働するリング（２００）を備える
ことを特徴とする請求項１から６までのいずれかに記載の注射装置。 A ring (200) that mechanically contacts and cooperates with the needle protection member (20) in the non-ejection position when the outer cap member (30) is mounted around the needle protection member (20). The injection device according to any one of claims 1 to 6, characterized in that: 前記注射装置は、自己注射器である
ことを特徴とする請求項１から７までのいずれかに記載の注射装置。 The injection device according to any one of claims 1 to 7 , wherein the injection device is a self-injector.
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FR1262066 2012-12-14
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PL2931338T3 (en) 2017-06-30
KR20150097601A (en) 2015-08-26
US10973984B2 (en) 2021-04-13
DK2931338T3 (en) 2017-02-20
EP2931338A1 (en) 2015-10-21
JP2016503672A (en) 2016-02-08
US20160106929A1 (en) 2016-04-21
WO2014091153A1 (en) 2014-06-19
KR102202396B1 (en) 2021-01-13
FR2999436A1 (en) 2014-06-20
CN105050641A (en) 2015-11-11
IL239047B (en) 2019-03-31
EP2931338B1 (en) 2016-11-30
FR2999436B1 (en) 2016-02-05

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